Production Operator

Help Us Build the Future of the Human Heart.
At BiVACOR, we're developing the world's most advanced total artificial heart, a technology capable of saving millions of lives around the world. We're a team united by purpose, working on something truly unprecedented. Every process you validate, every fixture you design, and every challenge you overcome plays a direct role in giving patients another shot at life. If that's the kind of work that gets you out of bed in the morning, we think you belong here.

About the Role This hands-on role contributes to the advancement of BiVACOR's innovative cardiovascular technology, requiring precision and attention to detail. This role plays a critical part in ensuring each device meets exacting standards before it reaches patients. The Product Operator is responsible for assembling, testing, and packaging medical devices in compliance with documented procedures, quality standards, and regulatory requirements (FDA 21 CFR Part 820, ISO 13485, ISO 14644).

Key Responsibilities

• Assemble, repair, inspect and/or test products following instructions.
• Proactively identifies and communicates quality issues and concerns
• Record information on approved documents.
• Dispose hazardous waste material in corresponding hazardous waste areas.
• Maintain training proficiency and certifications to remain in compliance
• Maintain compliance with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)
• Complete production records, batch documentation, and device history records accurately and in real-time.
• Immediately report deviations, non-conformances, or equipment malfunctions to supervisors.
• Maintain a culture of quality and accountability throughout the operations organization.

What You Bring

• High school diploma or equivalent.
• Minimum 1-2 years of experience in manufacturing, assembly, or production-preferably in medical devices, pharmaceuticals, or other regulated industries.
• Demonstrated ability to follow detailed instructions and document work accurately.
• Exceptional attention to detail and commitment to product quality.
• Strong focus on safety, cleanliness, and regulatory compliance.
• Ability to work both independently and as part of a team.
• Good communication skills for effective collaboration and reporting.
• Strong manual dexterity and hand-eye coordination, patience and care in handling delicate components.
• Proficiency in communication and understanding of English, including reading work instructions to consistently build defect free medical products

Preferred:

• Experience in Class III medical device assembly or other high-risk medical products.
• Familiarity with FDA QSR (21 CFR Part 820), ISO 13485, and ISO 14644 standards.
• Prior use of microscopes, precision measurement tools, and test equipment.
• Experience working in a cleanroom environment.
• Experience with Lean Manufacturing and related principles and working directly with the engineers to make continuous improvement changes.

What We Offer

BiVACOR offers a competitive compensation package and comprehensive benefits, including:

• 401(k) with company matching
• Medical, dental, and vision insurance
• Health Savings Account (HSA) & Flexible Spending Account (FSA)
• Life insurance & Employee Assistance Program
• Generous paid time off

The expected salary range for this position based in Huntington Beach California is $22.23 to $28.00 per hour. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Relocation benefits are not available for this posting

Apply today and be part of something extraordinary.

BiVACOR is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.